Study to compare Upright Self inflating bag with PEEP valve and T-piece resuscitator in resuscitation of Caesarean born infants of gestation age = 28 weeks
Phase 3
- Conditions
- Health Condition 1: O758- Other specified complications of labor and delivery
- Registration Number
- CTRI/2024/03/064214
- Lead Sponsor
- ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Pregnant women with gestation =28 weeks anticipating caesarean section (Gestational age will be assessed by last menstrual period [LMP] or early dating scan if LMP is not available)
Exclusion Criteria
1. Condition requiring immediate endotracheal intubation (CDH)
2. Suspected or confirmed major congenital malformation
3. Suspected or confirmed syndromes
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of PPV (primary outcome)Timepoint: 60 minutes of life
- Secondary Outcome Measures
Name Time Method 1. Proportion of newborn babies achieving a Heart rate =100 bpm at 2 minutes of life. <br/ ><br>2. Time duration required to reach HR=100bpm <br/ ><br>3. Time to reach =90% pre-ductal SpO2 (seconds) <br/ ><br>4. Need of oxygen during resuscitation. <br/ ><br>5. Maximum FiO2 required <br/ ><br>6. Expanded Apgar score at 1, 5 min (10 min, if applicable ) of life <br/ ><br>7. Evaluation for HIE using Sarnat and Sarnat staging <br/ ><br>8. Need of NICU admission <br/ ><br>9. Need of intubation <br/ ><br>10. Need of mechanical ventilation <br/ ><br>11. Mortality/morbidities (IVH/ air leaks)Timepoint: till 60 minutes of life